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Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

Primary Purpose

Hernia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MotifMESH

About this trial

This is an interventional treatment trial for Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired

Exclusion Criteria:

Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study

Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction

Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.

For subjects with Diabetes Mellitus, HbA1C <12%

BMI ≤ 40 kg/m²

Sites / Locations

Division of Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MotifMesh

Arm Description

Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh

Outcomes

Primary Outcome Measures

Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh

Hernia occurrence at one year after surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT01364233

First Posted

May 27, 2011

Last Updated

February 8, 2019

Sponsor

Medline Industries

1. Study Identification

Unique Protocol Identification Number

NCT01364233

Brief Title

Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

Official Title

A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medline Industries

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

Detailed Description

cPTFEi s a mesh-like product designed to reduce associated post surgical complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MotifMesh

Arm Type

Other

Arm Description

Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh

Intervention Type

Device

Intervention Name(s)

MotifMESH

Intervention Description

Polytetrafluoroethylene (cPTFE) macroporous mesh

Primary Outcome Measure Information:

Title

Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh

Description

Hernia occurrence at one year after surgery

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired Exclusion Criteria: Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study. For subjects with Diabetes Mellitus, HbA1C <12% BMI ≤ 40 kg/m²

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory A Dumanian, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Plastic Surgery

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

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